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UnknownNCT01533142

Bariatric Surgery on the West Coast of Norway (Vestlandet)

Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery

Status
Unknown
Phase
Study type
Observational
Enrollment
400 (estimated)
Sponsor
Helse Fonna · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods. This project is part of the regional strategic research initiative in the Helse Vest

Detailed description

Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints 400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.

Conditions

Interventions

TypeNameDescription
PROCEDUREBariatric surgeryPatients will be treated with one of two bariatric procedure:: sleeve gastrectomy or gastric bypass
PROCEDUREBariatric surgerySurgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy

Timeline

Start date
2012-02-01
Primary completion
2016-12-01
First posted
2012-02-15
Last updated
2016-02-19

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01533142. Inclusion in this directory is not an endorsement.